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Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Prediabetes (VICOX) (VICOX)

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ClinicalTrials.gov Identifier: NCT03356873
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:
The investigators aim to determine the effect of the correction of vitamin D in vitamin D deficient patients (<15ng/ml) in oxidative stress and insulin resistance in patients with impaired glucose tolerance. Vitamin D deficiency has been associated with chronic low-grade inflammation, diabetes mellitus type 2, cardiovascular risk and increased prevalence of coronary heart disease, cerebrovascular disease and myocardial infarction.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Glucose Intolerance Oxidative Stress Insulin Resistance Drug: Vitamin D Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Impaired Glucose Tolerance: A Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active
Vitamin D 5000 units capsules, 20 capsules per week during four weeks (total 400,000 units)
Drug: Vitamin D
Vitamin D supplementation
Placebo Comparator: Placebo
Identical placebo capsules, 20 capsules per week during four weeks
Other: Placebo
Placebo



Primary Outcome Measures :
  1. Oxidative stress [ Time Frame: One month ]
    Change in serum anti-oxidant capacity after one month


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: One month ]
    Change in insulin sensitivity after one month



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women, 18 to 70 years, glucose intolerance (post-2 hour 75-grams glucose load > or equal 140 mg/dl), 25-hydroxy vitamin D concentration < or equal 15 ng/ml

Exclusion Criteria:

  • Diabetes, systemic inflammatory disorders, treatment with statins, metformin or fibrates, renal insufficiency, intestinal malabsorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356873


Contacts
Contact: Paloma Almeda-Valdes, MD, PhD 525554870900 ext 2405 paloma.almedav@incmnsz.mx
Contact: Aili L Garcia-Tuomola, MD 525554870900 ext 2405 aililup@gmail.com

Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, Mexico, 14080
Contact: Aili L Garcia-Tuomola, MD    525554870900 ext 2405    aililup@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03356873     History of Changes
Other Study ID Numbers: DIA-981-13/14-1
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Insulin Resistance
Vitamin D Deficiency
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperglycemia
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents